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Job #03327

About our client Our client is the biotech division of a world-leading medical device company that has developed a reputation for successfully bringing complex products to the market in a variety of therapeutic areas. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for an Executive that wants to put their drive and initiative to work! Position Location Senior Clinical Research Specialist Tennessee Salary Highly competitive package, commensurate with experience Responsibilities 1) Support the development and implementation of major study group meetings, clinical studies, clinical advancement projects, evidence development, peer review publications/presentations and educational programs 2) Manage information flow from business partners in order to optimize support for the efforts of study site research coordinators 3) Maintain and track research support agreements 4) Manage study group activities 5) Work closely with key global surgeon leaders, external business partners, research institutions and Clinical Advancement as well as R&D in developing study group meeting agendas, logistics, study protocols, CRFs, IRB submissions, patient enrollment, follow-up and data collection 6) Coordinate and supervise internal/external resources in conducting clinical studies to ensure that study files, reports and clinical data are received, evaluated and entered into database management systems 7) Work with strategic business partners, key surgeon leaders and academic institutions in developing and implementing advanced logistics and systems for the acquisition, transfer, management and analysis of clinical data and digital radiographic images 8) Maintain a high level of professional expertise through familiarity with clinical literature, contemporary medical education and advancements in clinical care 9) Oversee research agreement management 10) Liaise with the Legal Department in developing and renewing research agreements (including completing and submitting requests for nondisclosure and research agreements) 11) Work with internal resources, subcontractors and strategic business partners to develop and manage the departmental research agreements database 12) Perform data entry and be accountable for accuracy of the departmental research agreement database 13) Provide basic review of all research agreements for tracking and database set-up 14) Track and process site-specific enrollment and follow-up reports from strategic business partners 15) Calculate and track research agreement payments 16) Serve as liaison to Accounts Payable Department in processing research agreement payments 17) Liaise with business partners, study group physician members and study site research coordinators 18) Work with strategic business partners (in consultation with study site lead coordinators) to create/revise study management reports to optimize their value 19) Act as first contact for study site lead coordinators on study management issues 20) Communicate with clinical sites and conduct periodic site visits where indicated 21) Monitor study enrollment and assist Study Site Lead coordinators in devising strategies to maintain high levels of enrollment and follow-up 22) Schedule and facilitate teleconferences as required to discuss data collection and data quality issues, disseminate study-related updates and coordinate study management planning 23) Provide guidance to study lead coordinators on study conduct 24) Organize and facilitate study group physician members in teleconferences as requested 25) Facilitate and support study group physician members and leaders in driving clinical research publication strategies Requirements 1) MS/BS in Life Science preferred or in a scientifically-related field with minimum 5 years of clinical research experience in a fast-paced medical or office environment 2) RN or BSN degree with 5 – 8 years of experience in clinical trials and site coordination (industry/institutional setting preferred) 3) 2 years of experience as an in-house CRA 4) Experience in clinical outcomes research, clinical trials, clinical data collection and management, GCPs as well as research protocol preparation 5) Excellent communication skills (written and oral) 6) Superb IT (MS Office, i.e. Word, PowerPoint and Excel), interpersonal, presentation, time management, project management skills 7) Good organizational, customer service, analytical and basic office machinery skills 8) Ability to maintain confidentiality in regard to contracts and personnel issues 9) Ability to work independently in a fast-paced, customer-driven, matrix style environment 10) Demonstrated ability to manage multiple tasks, prioritize workload, take ownership and work-flow initiative 11) Individual with good work ethics and strong attention to detail 12) Willingness to travel overnight regionally (less than 20%)